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Due to the small number of participants
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| Name | Class |
|---|---|
| Coalition for Epidemic Preparedness Innovations | OTHER |
| The Peter Doherty Institute for Infection and Immunity | OTHER |
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This is a single-blind, randomised controlled clinical trial to determine the reactogenicity and immunogenicity of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) vaccines (Pfizer-BioNTech or Moderna) as booster dose in adults, who have previously received either Pfizer-BioNTech or AstraZeneca as their primary doses.
Both fractional and standard doses of Pfizer-BioNTech or Moderna will be tested.
The trial intervention will be given in line with Australian Technical Advisory Group on Immunisation (ATAGI) recommendations for booster vaccine doses which allows booster doses from 5 months onwards . There will be a total of 8 groups, with 100 individuals of even spread of participants above and below 50 years in each group. The trial will be single site, based at Royal Children's Hospital, Melbourne, Australia
As per brief summary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Pfizer-BioNTech booster group | Active Comparator | Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine |
|
| Fractional Pfizer-BioNTech booster group | Experimental | Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine |
|
| Standard Elasomeran booster group | Active Comparator | Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine |
|
| Fractional Elasomeran booster group | Experimental | Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tozinameran - Standard dose | Biological | Tozinamrean is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS_CoV-2). A standard dose will be administered on day 0 of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| SARS-CoV-2 Specific Immunoglobulin (Ig)G Antibodies at 28-days Post Booster Vaccination | Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using the commercial Euroimmun S1 IgG ELISA. Data will be reported as binding antibody units/mL and presented as geometric mean concentration and 95% confidence intervals | 28-days post booster vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim Mulholland, MD | Murdoch Childrens Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Children's Hospital | Melbourne | Victoria | 3010 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34863358 | Background | Munro APS, Janani L, Cornelius V, Aley PK, Babbage G, Baxter D, Bula M, Cathie K, Chatterjee K, Dodd K, Enever Y, Gokani K, Goodman AL, Green CA, Harndahl L, Haughney J, Hicks A, van der Klaauw AA, Kwok J, Lambe T, Libri V, Llewelyn MJ, McGregor AC, Minassian AM, Moore P, Mughal M, Mujadidi YF, Murira J, Osanlou O, Osanlou R, Owens DR, Pacurar M, Palfreeman A, Pan D, Rampling T, Regan K, Saich S, Salkeld J, Saralaya D, Sharma S, Sheridan R, Sturdy A, Thomson EC, Todd S, Twelves C, Read RC, Charlton S, Hallis B, Ramsay M, Andrews N, Nguyen-Van-Tam JS, Snape MD, Liu X, Faust SN; COV-BOOST study group. Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial. Lancet. 2021 Dec 18;398(10318):2258-2276. doi: 10.1016/S0140-6736(21)02717-3. Epub 2021 Dec 2. |
| Label | URL |
|---|---|
| Quarter-dose of Moderna COVID vaccine still rouses a big immune response | View source |
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We will share de-identified data to ethically approved studies in cases where participants have indicated on the consent form that they consent to the use of their data and where consistent with terms of collaboration agreements.
Individual participant data (IPD) sharing plans in development
IPD sharing plans in development
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Participants who met the inclusion criteria and none of the exclusion criteria were randomised and assigned to one of the eight groups. However, due to the small number of participants enrolled, we have combined the groups based on the vaccine they received during the study and not stratify based on their previous vaccination history.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Pfizer-BioNTech Booster Group | Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine Tozinameran - Standard dose: Tozinamrean is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS_CoV-2). A standard dose will be administered on day 0 of the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2021 |
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Study participants who have received two doses of either Pfizer or Astrazena vaccine as their primary vaccine will be randomised into one of four groups. The four groups consists of a standard or fractional dose of either Pfizer or Moderna vaccine.
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The participants and those evaluating reactogenicity will be blinded to the vaccine allocation for the first 28 days following vaccination. After that, both clinical investigators and participants will be aware of their investigational product allocation. Laboratory staff will remain blinded to the investigational product allocation during the immunology testing.
|
|
| Tozinameran - fractional dose | Biological | Tozinamrean is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS_CoV-2). A fractional dose (15mcg) of the intervention will be administered on day 0 of the study. |
|
|
| Elasomeran - standard dose | Biological | Elasomeran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2). A single standard dose (50mcg) of the intervention will be administered on day 0 of the study. |
|
|
| Elasomeran - fractional dose | Biological | Elasomeran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2). A fractional dose (20mcg) of the intervention will be administered on day 0 of the study. |
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|
| US Food and Drug Administration (FDA). Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials 2007 | View source |
| FG001 | Fractional Pfizer-BioNTech Booster Group | Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine Tozinameran - fractional dose: Tozinamrean is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS_CoV-2). A fractional dose (15mcg) of the intervention will be administered on day 0 of the study. |
| FG002 | Standard Elasomeran Booster Group | Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine Elasomeran - standard dose: Elasomeran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2). A single standard dose (50mcg) of the intervention will be administered on day 0 of the study. |
| FG003 | Fractional Elasomeran Booster Group | Received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine Elasomeran - fractional dose: Elasomeran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2). A fractional dose (20mcg) of the intervention will be administered on day 0 of the study. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Pfizer-BioNTech Booster Group | Due to the small number of participants enrolled, we have combined the groups based on the vaccine they received (i.e. Standard Pfizer-BioNTech booster group) and did not stratify based on their previous vaccination history (i.e. received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine). Tozinameran - Standard dose: Tozinamrean is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS_CoV-2). A standard dose will be administered on day 0 of the study. |
| BG001 | Fractional Pfizer-BioNTech Booster Group | Due to the small number of participants enrolled, we have combined the groups based on the vaccine they received (i.e. fractional Pfizer-BioNTech booster group) and did not stratify based on their previous vaccination history (i.e. received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine). Tozinameran - fractional dose: Tozinamrean is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS_CoV-2). A fractional dose (15mcg) of the intervention will be administered on day 0 of the study. |
| BG002 | Standard Elasomeran Booster Group | Due to the small number of participants enrolled, we have combined the groups based on the vaccine they received (i.e. standard Elasomeran booster group) and did not stratify based on their previous vaccination history (i.e. received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine). Elasomeran - standard dose: Elasomeran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2). A single standard dose (50mcg) of the intervention will be administered on day 0 of the study. |
| BG003 | Fractional Elasomeran Booster Group | Due to the small number of participants enrolled, we have combined the groups based on the vaccine they received (i.e. fractional Elasomeran booster group) and did not stratify based on their previous vaccination history (i.e. received two doses of AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine). Elasomeran - fractional dose: Elasomeran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2). A fractional dose (20mcg) of the intervention will be administered on day 0 of the study. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Any reaction to primary vaccine | Count of Participants | Participants |
| ||||||||||||||||
| Medical status at enrolment | Count of Participants | Participants |
| ||||||||||||||||
| Currently taking medication | Count of Participants | Participants |
| ||||||||||||||||
| Ever tested positive to SARS-CoV-2 | Count of Participants | Participants |
| ||||||||||||||||
| Symptoms consistent with COVID-19 | Count of Participants | Participants |
| ||||||||||||||||
| Worst clinical spectrum of COVID-19 | Count of Participants | Participants |
| ||||||||||||||||
| BMI | Median | Inter-Quartile Range | kg/m2 |
| |||||||||||||||
| Temperature | Median | Inter-Quartile Range | celsius |
| |||||||||||||||
| Pulse rate pre COVID-19 booster dose | Median | Inter-Quartile Range | beats/min |
| |||||||||||||||
| Respiratory rate pre COVID-19 booster dose | Median | Inter-Quartile Range | breaths/min |
| |||||||||||||||
| Blood pressure pre- COVID-19 booster dose | Median | Inter-Quartile Range | mmHG |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | SARS-CoV-2 Specific Immunoglobulin (Ig)G Antibodies at 28-days Post Booster Vaccination | Serum samples collected at 28-days post booster vaccination from all groups will be evaluated for SARS-CoV-2 specific IgG antibodies using the commercial Euroimmun S1 IgG ELISA. Data will be reported as binding antibody units/mL and presented as geometric mean concentration and 95% confidence intervals | IgG antibody response 28-days post booster | Posted | Median | Inter-Quartile Range | binding antibody units (BAU/mL) | 28-days post booster vaccination. |
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7 days post vaccination
Any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and does not necessarily have a causal relationship with this treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Pfizer-BioNTech Booster Group | Due to the low enrolment numbers, the groups were combined based on the vaccine they received (Standard Pfizer-BioNTech) and not stratified based on their vaccination history (AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine). | 0 | 4 | 0 | 4 | 1 | 4 |
| EG001 | Fractional Pfizer-BioNTech Booster Group | Due to the low enrolment numbers, the groups were combined based on the vaccine they received (Fractional Pfizer-BioNTech) and not stratified based on their vaccination history (AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine). | 0 | 1 | 0 | 1 | 0 | 1 |
| EG002 | Standard Elasomeran Booster Group | Due to the low enrolment numbers, the groups were combined based on the vaccine they received (Standard Elasomeran) and not stratified based on their vaccination history (AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine). | 0 | 4 | 0 | 4 | 1 | 4 |
| EG003 | Fractional Elasomeran Booster Group | Due to the low enrolment numbers, the groups were combined based on the vaccine they received (Fractional Elasomeran) and not stratified based on their vaccination history (AstraZeneca or Pfizer-BioNTech as primary COVID-19 vaccine). | 0 | 4 | 0 | 4 | 0 | 4 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Throat infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Tiredness | Investigations | Systematic Assessment |
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Enrolment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ms Kathryn Bright | Murdoch Children's Research Institute | +61 3 99366656 | kathrynbright@mcri.edu.au |
| Dec 4, 2024 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| D000090983 | 2019-nCoV Vaccine mRNA-1273 |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
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| Male |
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| Filipino |
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| Korean |
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| Polish |
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| Serbian |
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| Southern and East African |
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| No |
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| *Pregnant (female only) |
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| Cardiovascular disease |
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| Cigarette use |
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| Anticoagulant therapy |
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| Yes |
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| Moderate |
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| Diastolic |
|